What side effects are associated with this type of intervention?

Common treatments for Bronchiolitis Obliterans Syndrome (BOS) with anti-inflammatory or immunomodulatory effects, such as corticosteroids and immunosuppressive agents, can have several side effects. Corticosteroids may cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Immunosuppressive agents, like tacrolimus or cyclophosphamide, can lead to nephrotoxicity, hepatotoxicity, increased susceptibility to infections, and potential malignancies. These side effects necessitate careful monitoring and management by healthcare providers.

What prior FDA approvals exist?

There are limited FDA-approved treatments specifically for Bronchiolitis Obliterans Syndrome (BOS). However, treatments with anti-inflammatory or immunomodulatory effects, such as corticosteroids and immunosuppressive agents, are commonly used to manage the condition. These treatments aim to reduce inflammation and prevent further lung damage, thereby improving quality of life. The trial of ARINA-1, which likely has similar anti-inflammatory or immunomodulatory effects, represents an ongoing effort to find more effective therapies for BOS.

What other types of research exist?

Promising alternatives to ARINA-1 for Bronchiolitis Obliterans Syndrome patients include nintedanib and pirfenidone, both of which have antifibrotic properties and are used in the treatment of idiopathic pulmonary fibrosis. Additionally, biologic agents such as abatacept and kinase inhibitors used in rheumatic diseases may also be considered for their immunomodulatory effects.

← Back to Search

Immunomodulator

ARINA-1 for Bronchiolitis Obliterans Syndrome

Phase 3

Recruiting

Led By Ramsey Hachem, MD

Research Sponsored by Renovion, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-75 years old at the time of consent

Be older than 18 years old

Must not have

Diagnosis of active congestive heart failure or symptomatic coronary artery disease > grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria

Chronic kidney disease stage IV or higher, including on dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing ARINA-1, a new treatment added to usual care, for lung transplant patients at risk of a serious lung condition called BOS. The goal is to see if ARINA-1 can prevent the condition from getting worse and improve patients' quality of life. The trial involves periodic health monitoring to track progress and any side effects.

Who is the study for?

This trial is for adults aged 18-75 who've had a bilateral lung transplant over a year ago and are experiencing a decline in lung function. They must be on stable medications, including azithromycin and immunosuppressants, willing to follow the study schedule, and women of childbearing age must use birth control. Exclusions include recent use of certain therapies or supplements, unresolved lung damage, severe heart or kidney disease, participation in other trials recently, and specific treatments within set timeframes.

What is being tested?

The trial tests ARINA-1 combined with standard care against standard care alone to see if it can prevent worsening of bronchiolitis obliterans syndrome (BOS) after lung transplants. It also looks at whether ARINA-1 helps maintain quality of life by reducing the need for increased immunosuppression therapy.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions related to new medications such as gastrointestinal issues, allergic reactions or skin rashes. Participants will have regular clinic visits and phone calls to monitor any adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe heart failure or coronary artery disease.

Select...

I have advanced kidney disease or am on dialysis.

Select...

I am currently taking an mTOR inhibitor or azathioprine.

Select...

My lung function has significantly decreased after my transplant.

Select...

I have ongoing lung damage that has not healed.

Select...

My lung scans show signs consistent with restrictive allograft syndrome.

Select...

I started or changed my maintenance therapy less than 14 days ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage change from baseline in FEV1 (%ΔFEV1)

Secondary study objectives

Change from baseline in Saint George's Respiratory Questionnaire total score

Number of participants in each arm with augmented immunosuppression

Percentage change from baseline of Forced Expiratory Volume in one second (FEV1)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of care onlyExperimental Treatment1 Intervention

Standard 3-therapy immunosuppression regimen and azithromycin

Group II: ARINA-1 plus standard of careExperimental Treatment1 Intervention

ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization plus standard 3-therapy immunosuppression regimen and azithromycin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARINA-1

2022

Completed Phase 2

~40

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bronchiolitis Obliterans Syndrome (BOS) include corticosteroids, immunosuppressive agents, and other anti-inflammatory medications. These treatments work by reducing inflammation and modulating the immune response, which are critical in preventing the progression of BOS. Corticosteroids help to decrease the inflammatory response in the airways, while immunosuppressive agents like tacrolimus and azathioprine inhibit the immune system's activity to prevent further damage to lung tissue. These mechanisms are essential for BOS patients as they help to preserve lung function, reduce symptoms, and improve overall quality of life.